Recall Z-2300-2008 ยท LXH Orthopedic Manual Surgical Instrument
Zimmer Inc.
Zimmer M/G Unicompartmental Knee System headed screw, 48 mm length, sterile, Catalog No. 00-5791-041-00. Used during surgery for the cutting guide. This screw is not permanently implanted.
| Date | Sep 17, 2008 (initiated Jun 30, 2008) |
| Status | Terminated |
| Reason | An impurity in the metal may affect the strength of the screw, resulting in breakage and/or surgical delays. |
| Root cause | Nonconforming Material/Component |
| Action | Zimmer instructed consignees by a letter, dated June 30, 2008, sent via mail or email, to return the product. |
| Quantity | 5 |
| Distribution | Florida, China and India. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.